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A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Sponsor: The Netherlands Cancer Institute
Summary
Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: * Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects * Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-02-29
Completion Date
2027-04-02
Last Updated
2026-02-04
Healthy Volunteers
No
Conditions
Interventions
De-escalated radiotherapy
5 fraction de-escalated dose SBRT protocol
Locations (1)
Netherlands Cancer Institute
Amsterdam, Netherlands